A PHASE IIIB, RANDOMIZED, TRIAL OF OPEN-LABEL EFAVIRENZ OR ATAZANAVIR WITH RI

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 具体目标： 主要研究内容： 三个主要目标是： 1.比较病毒学失败的方案之间的病毒学疗效，定义为在16周或之后与24周前或24周前确认血浆HIV-1 RNA水平=1000拷贝/毫升或在24周或之后确认为200拷贝/毫升的时间。 2.比较安全性定义为首次出现3级或4级体征、症状或实验室异常且至少比基线高一级的安全性的方案之间的安全性。 3.比较不同治疗方案之间的耐受性，耐受性定义为在初始治疗方案中更换一种或多种药物的时间。 代谢子研究： 主要目标是： 1.评估在含有ABC/3TC或FTC/TDF(B/D或A/C)的ARV方案开始后，治疗臂内外周脂肪变化(肢体脂肪)的变化。 2.比较使用ABC/3TC和FTC/TDF两种ARV方案对腰椎和髋部的骨密度(BMD)的影响。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. SPECIFIC AIMS: Main Study: The three primary objectives are: 1. To compare virologic efficacy between regimens with virologic failure defined as the time to confirmed plasma HIV-1 RNA level =1000 copies/mL at or after 16 weeks and before 24 weeks or =200 copies/mL at or after week 24. 2. To compare the safety between regimens with safety defined as the time to first development of Grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline. 3. To compare the tolerability between regimens with tolerability defined as the time to change in one or more drugs in the initial treatment regimen. Metabolic Sub-Study: The primary objectives are: 1. To assess changes within treatment arms in peripheral fat changes (limb fat) after the initiation of an ARV regimen containing ABC/3TC or FTC/TDF (Arms B/D or A/C). 2. To compare the effects of initiation of an ARV regimen containing ABC/3TC with those of a regimen containing FTC/TDF on bone mineral density (BMD), as assessed by lumbar spine and hip DEXA (Arms B/D versus A/C).